Study of Blood and Tissue Samples From Patients With Aggressive Non-Hodgkin B-Cell Lymphoma or Hodgkin Lymphoma
Evaluation of Serum Free Light Chains and Clonal Ig DNA in Plasma From Patients With Aggressive B-Cell Lymphomas
3 other identifiers
observational
52
1 country
16
Brief Summary
RATIONALE: Studying samples of blood and tissue from patients with cancer in the laboratory may help doctors learn more about changes that occur in DNA and identify biomarkers related to cancer. PURPOSE: This research study is looking at blood and tissue samples from patients with aggressive non-Hodgkin B-cell lymphoma or Hodgkin lymphoma.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for all trials
Started Aug 2009
Longer than P75 for all trials
16 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
August 1, 2009
CompletedFirst Submitted
Initial submission to the registry
September 19, 2009
CompletedFirst Posted
Study publicly available on registry
September 22, 2009
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2013
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2013
CompletedAugust 7, 2020
August 1, 2020
3.8 years
September 19, 2009
August 6, 2020
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Proportion of patients with diffuse large B-cell/immunoblastic and Burkitt histologies with elevated serum free light chains (FLC)
Study entry
Proportion of patients with Hodgkin lymphoma clonal immunoglobulin (Ig) DNA detection in the plasma
Study entry
Secondary Outcomes (6)
Agreement between the detection of a monoclonal Ig DNA spike in plasma and the detection of a monoclonal DNA spike in tumor tissue
Study entry
Agreement between the fragment length of a spike in tumor tissue and the fragment length of the spike in plasma
Study entry
Detection rate of elevated FLC in each histology, including diffuse large B-cell/immunoblastic and Burkitt lymphoma
Study entry
Detection rate of clonal Ig DNA in each histology, including diffuse large B-cell/immunoblastic, Burkitt lymphoma, and Hodgkin lymphoma
Study entry
Analysis of the clinical and pathologic correlates of detection by the serum/plasma tests: disease subtype, stage of disease, disease bulk, lactate dehydrogenase, and Ki67 index
Study entry
- +1 more secondary outcomes
Study Arms (1)
Specimen Collection
Subjects with a diagnosis of HIV and an untreated aggressive B-cell lymphoma.
Interventions
determination of elevated serum FLC and clonal Ig detection rates in plasma and tumor
determination of elevated serum FLC and clonal Ig detection rates in plasma and tumor
Eligibility Criteria
Persons with HIV infection and a diagnosis of an untreated aggressive B-cell lymphoma.
Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.
Sponsors & Collaborators
- AIDS Malignancy Consortiumlead
- National Cancer Institute (NCI)collaborator
- The Emmes Company, LLCcollaborator
Study Sites (16)
Rebecca and John Moores UCSD Cancer Center
La Jolla, California, 92093-0658, United States
UCLA Clinical AIDS Research and Education (CARE) Center
Los Angeles, California, 90024, United States
University of California at Davis Center for Aids Research and Education Services
Sacramento, California, 95814, United States
UCSF Helen Diller Family Comprehensive Cancer Center
San Francisco, California, 94115, United States
University of Miami
Miami, Florida, 33136, United States
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Baltimore, Maryland, 21231-2410, United States
Boston University Cancer Research Center
Boston, Massachusetts, 02118, United States
Mallinckrodt Institute of Radiology at Washington University Medical Center
St Louis, Missouri, 63110, United States
Siteman Cancer Center at Barnes-Jewish Hospital - Saint Louis
St Louis, Missouri, 63110, United States
Memorial Sloan-Kettering Cancer Center
New York, New York, 10021, United States
Montefiore Medical Center
The Bronx, New York, 10467-2490, United States
UNC Hospitals, The University of North Carolina at Chapel Hill
Chapel Hill, North Carolina, 27599, United States
Pennsylvania Oncology Hematology Associates, Incorporated - Philadelphia
Philadelphia, Pennsylvania, 19106, United States
Thomas Street Health Center
Houston, Texas, 77009, United States
Baylor University Medical Center - Houston
Houston, Texas, 77030-2707, United States
Benaroya Research Institute at Virginia Mason Medical Center
Seattle, Washington, 98101, United States
Related Publications (1)
Wagner-Johnston ND, Lensing S, Noy A, Ratner L, Henry D, Lee JY, Silver S, Faham M, Ambinder RF. High frequency of identical clonal immunoglobulin DNA in pre-treatment tumor and plasma from untreated patients with HIV-associated lymphoma: prospective multicenter trial of the AIDS malignancies consortium (AMC 064). Leuk Lymphoma. 2017 Dec;58(12):2939-2942. doi: 10.1080/10428194.2017.1317095. Epub 2017 May 16.
PMID: 28508728DERIVED
Biospecimen
5 tubes of peripheral blood collected along with available tissue blocks or fresh frozen tissue collected at baseline.
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Nina Wagner-Johnston, MD
Mallinckrodt Institute of Radiology at Washington University Medical Center
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- NETWORK
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
September 19, 2009
First Posted
September 22, 2009
Study Start
August 1, 2009
Primary Completion
June 1, 2013
Study Completion
June 1, 2013
Last Updated
August 7, 2020
Record last verified: 2020-08